NCT02834455

Rational Approach to a Unilateral Pleural Effusion2

Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Simon Reuter · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and \<33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies. Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions \>10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone. Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics. The investigators will perform two randomized studies to investigate whether 1. PET/CT is comparable to CT alone 2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DEVICE	Contrast-enhanced CT	50% of patients with unilateral pleural effusion will have performed a CE-CT
DEVICE	PET-CT	50% of patients with unilateral pleural effusion will have performed a PET-CT

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2016-07-15
• Last updated: 2020-12-17

Locations

1 site across 1 country: Denmark